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FDA approves premarket application for melanoma device
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The FDA has accepted the premarket approval application for MelaFind, a device used to gain additional information on indeterminate pigmented skin lesions to help physicians make decisions regarding biopsy.
Mela Sciences, the manufacturer of MelaFind, submitted a premarket approval application to the FDA in June 2009. Data from a 1,383-participant trial and a companion reader study of 110 dermatologists were included. The device was associated with 98% sensitivity; the rate was similar in the reader study vs. 72% sensitivity for participating dermatologists.
The device received approval in the European Union in September. It is expected to be available in the northeastern United States in 2012.
To start, the device will be placed in select, high-volume integrated dermatology and skin cancer specialists' practices, according to a press release.
MelaFind is not intended for use to confirm a clinical diagnosis of melanoma, but should be used when a dermatologist wants to obtain additional information for a decision to biopsy. In addition, it is intended for clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, not those with a clinical diagnosis of melanoma or likely melanoma.
The device should only be used on lesions that are 2 mm to 22 mm in diameter; are accessible by the MelaFind imager; sufficiently pigmented; do not contain a scar or fibrosis consistent with previous trauma; are non-ulcerated or non-bleeding; are more than 1 cm away from the eye; do not contain foreign matter; and are not on special anatomic sites.
Lesions classified as positive according to the device should be considered for biopsy, and the biopsy decision of a negative lesion should be based on the remainder of the entire clinical context, according to the press release. Those classified as "non-evaluable" lesions on MelaFind should be re-evaluated for biopsy.
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